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FDA 510(k)

FIX. & LENS FOR. #'S 3510,3512,3248,3795

K-Number: K791986 · 1979-10-04

ApplicantEdward Weck, Inc.
Decision Date1979-10-04
Product CodeHNR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FIX. & LENS FOR. #'S 3510,3512,3248,3795 is the device name listed in this FDA 510(k) record. The listed applicant is Edward Weck, Inc.. It received FDA 510(k) clearance on 1979-10-04 under 510(k) number K791986. The device is classified under product code HNR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIX. & LENS FOR. #'S 3510,3512,3248,3795?

FIX. & LENS FOR. #'S 3510,3512,3248,3795 is a medical device that received FDA 510(k) clearance on 1979-10-04. The listed applicant is Edward Weck, Inc.. The 510(k) number is K791986.

When did FIX. & LENS FOR. #'S 3510,3512,3248,3795 receive FDA 510(k) clearance?

FIX. & LENS FOR. #'S 3510,3512,3248,3795 received FDA 510(k) clearance on 1979-10-04, under 510(k) number K791986.

Who is the listed applicant for FIX. & LENS FOR. #'S 3510,3512,3248,3795?

The FDA 510(k) record lists Edward Weck, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIX. & LENS FOR. #'S 3510,3512,3248,3795?

The FDA product code for FIX. & LENS FOR. #'S 3510,3512,3248,3795 is HNR.

Other records listing Edward Weck, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K915378WECK TROCARK914690LM15(TM), CATALOG NUMBER - 523821K911915HEMOCLIP IIK914470PNEUMO-SEAL(TM)K911272ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705K902108HEM-O-LOK(TM)

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Related Devices (Code: HNR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K022835STEPHENS DISPOSABLE FORCEPSStephens InstrumentsK895434ALCON FOLDING FORCEPSAlcon LaboratoriesK891487SOFT LENS FOLDING BLOCKWestern Medical Products, Inc.K893199PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTRAllergan Medical OpticsK885230MCDONALD FOLDING FORCEPSAlcon LaboratoriesK881049BRADBURY INTRAOCULAR RETINAL KIT CAT #200Microline Pentax, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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